Efficacy of an Intranasal Stent on Nasal Obstruction at Night (RHINASTENT)

Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study

This study aims to demonstrate a decrease with normalization of nasal resistance in the forward decubital position and with an intra-nasal stent in patients with nasal obstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients consulting for nasal obstruction at night and who have functional nasal test with pathological resistance in decubitus position are included.

Functional nasal test (non invasive tests) will be performed before and after intranasal introduction of a stent: anterior rhinomanometry to measure nasal function by the measure of resistance and acoustic rhinometry to measure the geometry of nasal fossa by the measure of minimal sectional cross area sitting, after 30 minutes of decubitus then new measurements with a stent in decubitus position in each nostril .

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ile De France
      • Créteil, Ile De France, France, 94000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Volontary patient
  2. Over 18 years old or more.
  3. Complain of a nasal obstruction more important (or only) at night (in decubitus position)

Exclusion Criteria:

  1. Unability to sign the consent form
  2. Allergy of stent component
  3. Perforation of nasal septum
  4. Haemostasis disorder or anticoagulant therapy
  5. Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Device : nasal airway stent
All patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus.
Patients with Nasal obstruction at night, will be used intrasal stent during 15 nights. These are flexible silicone tubes that are lubricated and easy to insert into the nasal cavities, which would restore the permeability of the nasal cavities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal resistance in anterior rhinomanometry (sPa/ml/sec)
Time Frame: Day 15
Change grom Baseline of Nasal resistance in anterior rhinomanometry. Sitting, lying in the meadow and Per stent nasal.
Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal Obstruction and Septoplasty Effectiveness (NOSE)
Time Frame: Day 15
Scale [0-100] The higher the score, the more the quality of life is impaired.
Day 15
Analog visual scale (EVA) of nocturnal nasal obstruction
Time Frame: Day 15
Scale [0-10] The higher the score, the stronger the feeling of nasal obstruction.
Day 15
Sino-Nasal Outcome Test 22 (SNOT-22) questionary
Time Frame: Day 15
Scale [0-100]. The total score can range from 0 to 110, with values increasing as the severity of symptoms worsens
Day 15
Epworth Sleepiness Scale (ESS)
Time Frame: Day 15
Scale [0-24] The higher the score, the more the quality of life is impaired.
Day 15
Compliance
Time Frame: Day 15
Questionnaire on the use or non-use of the stent
Day 15
Stent satisfaction
Time Frame: Day 15
Number of patients satisfied with the stent
Day 15
Stent tolerance
Time Frame: Day 15
Questionnaire on stent tolerance or non-tolerance
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Actual)

September 30, 2022

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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